Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 1 of 22 PageID #: 3298
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`ABBVIE INC. and GENENTECH, INC.,
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`Plaintiffs,
`
`v.
`DR. REDDY’S LABORATORIES, LTD.,
`and DR. REDDY’S LABORATORIES, INC.
`
`Defendants.
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`
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`C.A. No. 1:20-cv-00968-MSG
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`CONSOLIDATED
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`SECOND AMENDED COMPLAINT AGAINST DRL
`FOR PATENT INFRINGEMENT
`
`Plaintiffs AbbVie Inc. (“AbbVie”) and Genentech, Inc. (“Genentech”) (collectively,
`
`
`
`“Plaintiffs”), by their undersigned attorneys, bring this action against Defendants Dr. Reddy’s
`
`Laboratories, Inc. (“DRLI”) and Dr. Reddy’s Laboratories, Ltd. (“DRLL”) (collectively,
`
`“Defendants” or “DRL”), and hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
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`This action for patent infringement, brought pursuant to the patent laws of
`
`the United States, 35 U.S.C. §§ 1 et seq., arises from DRL’s submission to the United States Food
`
`and Drug Administration (“FDA”) of an Abbreviated New Drug Application (“ANDA”) No.
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`214733 (“DRL’s ANDA”) seeking approval to market a generic version of Plaintiffs’ highly
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`successful pharmaceutical product VENCLEXTA®, prior to the expiration of the patents listed in
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`the Approved Drug Products with Therapeutic Equivalence Evaluations (an FDA publication
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`commonly known as the “Orange Book”) for VENCLEXTA®. The Orange Book-listed patents
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`are U.S. Patent Nos. 8,546,399 (“the ’399 Patent”), 9,174,982 (“the ’982 Patent”), 8,722,657 (“the
`
`’657 Patent”), 9,539,251 (“the ’251 Patent”), 10,730,873 (“the ’873 Patent”), 10,993,942 (“the
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`
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`DRL EXHIBIT 1005 PAGE 1
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`

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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 2 of 22 PageID #: 3299
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`’942 Patent”), and 11,110,087 (“the ’087 Patent”). The ’399 Patent, the ’982 Patent, the ’657
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`Patent, the ’873 Patent, the ’942 Patent, and the ’087 Patent are collectively referred to as “the
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`Patents-in-suit.”
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`VENCLEXTA®
`
`2.
`
`VENCLEXTA® (venetoclax) is a ground-breaking drug which has gained
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`widespread acceptance in the medical community. It has been used to treat over 31,000 patients
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`in the United States and around the world who suffer from chronic lymphocytic leukemia (“CLL”),
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`small lymphocytic lymphoma (“SLL”), and, as part of a combination therapy, acute myeloid
`
`leukemia (“AML”).
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`3.
`
`VENCLEXTA® selectively targets and inhibits the B-cell CLL/lymphoma
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`2 (“BCL-2”) protein and is the first FDA-approved BCL-2 inhibitor. BCL-2 prevents apoptosis,
`
`or programmed cell death, which is the process for removal of aged or damaged cells.
`
`4.
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`VENCLEXTA® was first approved by the FDA on April 11, 2016 pursuant
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`to New Drug Application (“NDA”) No. 208573. It is available as an oral tablet containing 10 mg,
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`50 mg, or 100 mg of venetoclax as the active pharmaceutical ingredient.
`
`5.
`
`VENCLEXTA® is currently approved for use and indicated as follows: (1)
`
`for the treatment of adult patients with CLL or SLL; (2) in combination with azacitidine, or
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`decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults who are
`
`age 75 years or older, or who have comorbidities that preclude use of intensive induction
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`chemotherapy.
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`6.
`
`AbbVie and Genentech co-market and sell VENCLEXTA® in the United
`
`States and other parts of the world. They have invested hundreds of millions of dollars to discover
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`DRL EXHIBIT 1005 PAGE 2
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 3 of 22 PageID #: 3300
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`venetoclax and develop VENCLEXTA®, including investing significant resources investigating
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`whether VENCLEXTA® alone and in combination with other drugs can treat other types of cancer.
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`7.
`
`The FDA has recognized the innovative nature of VENCLEXTA® in
`
`granting it six breakthrough therapy designations: (1) treatment of patients with relapsed or
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`refractory CLL who harbor the 17p deletion mutation; (2) treatment of patients with relapsed or
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`refractory CLL in combination with the anti-CD20 antibody rituximab (Rituxan®); (3) venetoclax
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`in combination with hypomethylating agents for the treatment of patients with untreated
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`(treatment-naïve) AML who are ineligible to receive standard induction therapy (high-dose
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`chemotherapy); (4) combination of venetoclax and low-dose cytarabine for treatment-naïve
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`patients with AML, who are ineligible for intensive chemotherapy; (5) venetoclax in combination
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`with obinutuzumab for the treatment of adult patients with CLL; and (6) combination of venetoclax
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`plus azacitidine as a potential systemic therapy for patients with treatment-naïve myelodysplastic
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`syndrome whose disease is considered to be intermediate-, high-, or very high–risk. A
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`breakthrough designation is reserved for a drug intended to treat a serious condition where
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`preliminary clinical results indicate that the drug may demonstrate substantial improvement over
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`available therapies.
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`8.
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`VENCLEXTA® has one of the most robust clinical oncology development
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`programs for a single molecule in the industry, with approximately 212 ongoing clinical trials
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`(including 30 Phase 3 trials).
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`9.
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`In addition to being well-received by the FDA and the medical community,
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`VENCLEXTA® received the biomedical industry’s highest accolade in 2017 when it was awarded
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`the Prix Galien Award for Best Pharmaceutical Product.
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`-3-
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`DRL EXHIBIT 1005 PAGE 3
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 4 of 22 PageID #: 3301
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`THE PARTIES
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`10.
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`Plaintiff AbbVie is a corporation organized and existing under the laws of
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`the state of Delaware, with its corporate headquarters at 1 North Waukegan Road, North Chicago,
`
`Illinois 60064. AbbVie is a global research and development-based biopharmaceutical company
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`committed to developing innovative therapies for some of the world’s most complex and critical
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`conditions. The company’s mission is to use its expertise, dedicated people, and unique approach
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`to innovation to markedly improve treatments across therapeutic areas, including in oncology.
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`AbbVie holds NDA No. 208573 for VENCLEXTA® and is an assignee of all Patents-in-suit.
`
`11.
`
`Plaintiff Genentech is a corporation organized under the laws of the State
`
`of Delaware, with its principal place of business at 1 DNA Way, South San Francisco, California
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`94080. Genentech is a biotechnology company dedicated to pursuing ground-breaking science to
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`discover and develop medicines for people with serious and life-threatening diseases. Genentech
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`is an assignee of the ’399, ’982, ’942, and ’087 Patents and an exclusive licensee of the ’657 and
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`’873 Patents.
`
`12.
`
`On information and belief, Defendant DRLL is a company organized and
`
`existing under the laws of India, with its principal place of business at 8-2-337, Road No. 3,
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`Banjara Hills, Hyderabad 500034, India.
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`13.
`
`On information and belief, Defendant DRLI is a corporation organized and
`
`existing under the laws of the States of New Jersey with its principal place of business at 107
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`College Road East, Princeton, New Jersey 08540.
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`14.
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`On information and belief, Defendants are agents of one another and/or
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`operate in concert as integrated parts of the same business group.
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`15.
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`On information and belief, DRLI is a wholly owned subsidiary of DRLL
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`and acts as its authorized agent in the United States.
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`-4-
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`DRL EXHIBIT 1005 PAGE 4
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 5 of 22 PageID #: 3302
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`16.
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`On information and belief, DRLL, itself and through its wholly owned
`
`subsidiary DRLI, develops, manufactures, markets, sells, and/or imports generic versions of
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`branded pharmaceutical products throughout the United States, including in this Judicial District.
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`17.
`
`On information and belief, DRLI, itself and through DRLL, is in the
`
`business of developing, manufacturing, and/or distributing generic drugs for marketing, sale,
`
`and/or use throughout the United States, including in this Judicial District.
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`18.
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`On information and belief, DRLL is the holder of Drug Master File 33669
`
`for venetoclax.
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`19.
`
`On information and belief, and as described in Defendants’ written
`
`notification of DRL’s ANDA and its accompanying § 505(j)(2)(A)(vii)(IV) certifications received
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`June 8, 2020 (“DRL’s June Notice Letter”) and September 4, 2020 (“DRL’s September Notice
`
`Letter”) (collectively, “DRL’s Notice Letters”), Defendants caused DRL’s ANDA to be submitted
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`to the FDA and seek FDA approval of DRL’s ANDA prior to the expiration of the patents listed
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`in the Orange Book for VENCLEXTA®.
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`20.
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`On information and belief, DRL intends to commercially manufacture,
`
`market, offer for sale, and sell the proposed generic venetoclax tablets described in DRL’s ANDA
`
`(“DRL’s Generic Version”) throughout the United States, including in the State of Delaware, in
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`the event the FDA approves DRL’s ANDA.
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`JURISDICTION & VENUE
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`21.
`
`This civil action for patent infringement arises under the Patent Laws of the
`
`United States and the Food and Drug Laws of the United States, Titles 35 and 21, United States
`
`Code.
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`22.
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`This Court has jurisdiction over the subject matter of this action pursuant to
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`28 U.S.C. §§ 1331 and 1338(a).
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`
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`-5-
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`DRL EXHIBIT 1005 PAGE 5
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 6 of 22 PageID #: 3303
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`23.
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`In DRL’s Answer to the original Complaint in this action, DRL stated that
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`“for purposes of this action only, DRL does not contest personal jurisdiction in this judicial
`
`district.” (D.I. 9, at ¶¶ 23, 30-31).
`
`24.
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`This Court has personal jurisdiction over Defendants by virtue of, inter alia,
`
`on information and belief, Defendants having availed themselves of the rights and benefits of the
`
`laws of the State of Delaware by engaging in substantial, continuous, and systematic contacts with
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`the State of Delaware and because Defendants intend to indirectly or directly market, sell, and/or
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`distribute generic drugs, including DRL’s Generic Version, to residents of this State. Accordingly,
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`Defendants should reasonably anticipate being hauled into court in this Judicial District.
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`25.
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`On information and belief, Defendants acting in concert and/or as agents of
`
`one another filed DRL’s ANDA.
`
`26.
`
`On information and belief, Defendants acting in concert and/or as agents of
`
`one another will market, distribute, and/or sell DRL’s Generic Version in the United States,
`
`including in Delaware, upon approval of DRL’s ANDA, and will derive substantial revenue from
`
`the sale of DRL’s Generic Version.
`
`27.
`
`On information and belief, DRL’s Generic Version will be used within and
`
`throughout the United States, including in Delaware.
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`28.
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`On information and belief, DRL’s Generic Version will be prescribed by
`
`physicians practicing in Delaware, dispensed by pharmacies located within Delaware, and used by
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`patients in Delaware.
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`29.
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`This Court also has personal jurisdiction over Defendants by virtue of, inter
`
`alia, the fact that they have committed, aided, abetted, contributed to, and/or participated in the
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`commission of a tortious act of patent infringement under 35 U.S.C. § 271(e)(2) that has led to
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`-6-
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`DRL EXHIBIT 1005 PAGE 6
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 7 of 22 PageID #: 3304
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`and/or will lead to foreseeable harm and injury to Plaintiffs, with both Plaintiffs being organized
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`under the laws of the State of Delaware.
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`30.
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`This Court also has personal jurisdiction over DRLI because, inter alia,
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`DRLI, on information and belief, is registered as a pharmacy wholesaler under license
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`No. A-4-0002524 and as a controlled substances distributor/manufacturer under license
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`No. DM-0013148 with the Delaware Division of Professional Regulation.
`
`31.
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`This Court also has personal jurisdiction over DRLL and DRLI because
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`they have previously been sued, individually or together, in this Judicial District and have not
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`challenged personal jurisdiction or venue, and have purposefully availed themselves of the rights
`
`and benefits of the jurisdiction of this Court by filing claims and counterclaims in this Judicial
`
`District. See, e.g., Novartis Pharm. Corp. et al. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs.,
`
`Ltd., C.A. No. 19-2053-LPS (D. Del. Feb. 6, 2020), D.I. 34; Genzyme Corp. et al. v. Dr. Reddy’s
`
`Labs., Inc. and Dr. Reddy’s Labs., Ltd., C.A. No. 19-2045-CFC (D. Del. Nov. 20, 2019), D.I. 8;
`
`Boehringer Ingelheim Pharm. Inc. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd., C.A.
`
`No. 19-1495-CFC (D. Del. Sep. 4, 2019), D.I. 9; Genzyme Corp. et al. v. Dr. Reddy’s Labs., Inc.
`
`and Dr. Reddy’s Labs., Ltd., C.A. No. 18-1839-CFC (D. Del. Jan. 16, 2019), D.I. 13; Pfizer Inc.
`
`et al. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd., C.A. No. 19-750-CFC (D. Del. Jul.
`
`15, 2019), D.I. 12; Onyx Therapeutics, Inc. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd.,
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`C.A. No. 17-1811-LPS (D. Del. Jan. 23, 2018), D.I. 11; Viiv Healthcare Co. et al. v. Dr. Reddy’s
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`Labs., Inc. and Dr. Reddy’s Labs., Ltd., C.A. No. 17-1678-MSG (D. Del. Feb. 12, 2018), D.I. 13;
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`Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd. v. GlaxoSmithKline LLC et al., C.A. No. 18-
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`cv-0548-LPS (D. Del. Apr. 12, 2018), D.I. 1; Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd.
`
`v. Fresenius Kabi USA, LLC, C.A. No. 15-cv-0714-RGA (D. Del. Aug. 18, 2015), D.I. 1.
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`
`
`-7-
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`DRL EXHIBIT 1005 PAGE 7
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`

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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 8 of 22 PageID #: 3305
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`32. Moreover, this Court has jurisdiction over DRLL pursuant to Fed. R. Civ.
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`P. 4(k)(2) because: (a) Plaintiffs’ claims arise under federal law; (b) DRLL is a foreign defendant
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`not subject to personal jurisdiction in the courts of any state; and (c) DRLL has sufficient contacts
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`with the United States as a whole, including, but not limited to, submitting various ANDAs to the
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`FDA, and manufacturing and selling pharmaceutical products distributed throughout the United
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`States, such that this Court’s exercise of jurisdiction over DRLL satisfies due process.
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`33.
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`In DRL’s Answer to the original Complaint in this action, DRL stated that
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`“it does not contest venue in this Court for purposes of this action only.” (D.I. 9, at ¶ 32).
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`34.
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`Venue is proper in this Judicial District for DRL pursuant to 28 U.S.C. §§
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`1391 and/or 1400 because, on information and belief, inter alia, DRLL is a company organized
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`and existing under the laws of India, and may be sued in any judicial district pursuant to 28 U.S.C.
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`§ 1391(c) and DRL’s Generic Version will be prescribed by physicians practicing in Delaware,
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`dispensed by pharmacies located within Delaware, and used by patients in Delaware. Each of
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`these activities would have a substantial effect within Delaware and would constitute an act of
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`infringement of the Patents-in-suit if DRL’s Generic Version is approved before the Patents-in-
`
`suit expire.
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`35.
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`Venue is further proper against DRLI as it is the agent or alter ego of DRLL
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`(which is also subject to venue in this Judicial District) in connection with the submission of DRL’s
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`ANDA. Moreover, DRLI has litigated other Hatch-Waxman patent infringement disputes in this
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`Judicial District.
`
`36.
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`In addition, venue is also proper in this Court because DRLI and DRLL
`
`have not objected to Plaintiffs’ July 7, 2020 request that they consent to venue in this Judicial
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`District for the purposes of this action.
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`-8-
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`DRL EXHIBIT 1005 PAGE 8
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 9 of 22 PageID #: 3306
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`THE ASSERTED PATENTS
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`37.
`
`The ’399 Patent, titled “Apoptosis Inducing Agents for the Treatment of
`
`Cancer and Immune and Autoimmune Diseases,” was duly and legally issued by the United States
`
`Patent and Trademark Office (“USPTO”) on October 1, 2013. A true and correct copy of the ’399
`
`patent is attached as Exhibit A.
`
`38.
`
`The ’399 Patent is assigned to AbbVie, Genentech, and the Walter and Eliza
`
`Hall Institute of Medical Research.
`
`39.
`
`The ’982 Patent, titled “Apoptosis-Inducing Agents for the Treatment of
`
`Cancer and Immune and Autoimmune Diseases,” was duly and legally issued by the USPTO on
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`November 3, 2015. A true and correct copy of the ’982 patent is attached as Exhibit B.
`
`40.
`
`The ’982 Patent is assigned to AbbVie, Genentech, and the Walter and Eliza
`
`Hall Institute of Medical Research.
`
`41.
`
`The ’657 Patent, titled “Salts and Crystalline Forms of an Apoptosis-
`
`Inducing Agent,” was duly and legally issued by the USPTO on May 13, 2014. A true and correct
`
`copy of the ’657 patent is attached as Exhibit C.
`
`42.
`
`The ’657 Patent is assigned to AbbVie and exclusively licensed to
`
`Genentech.
`
`43.
`
`The ’873 Patent, titled “Salts and Crystalline Forms of an Apoptosis-
`
`Inducing Agent,” was duly and legally issued by the USPTO on August 4, 2020. A true and correct
`
`copy of the ’873 Patent is attached as Exhibit D.
`
`44.
`
`The ’873 Patent is assigned to AbbVie and exclusively licensed to
`
`Genentech.
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`-9-
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`DRL EXHIBIT 1005 PAGE 9
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 10 of 22 PageID #: 3307
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`45.
`
`The ’942 Patent, titled “Combination Therapy of a Type II Anti-CD20
`
`Antibody with a Selective BCL-2 Inhibitor,” was duly and legally issued by the USPTO on May
`
`4 , 2021. A true and correct copy of the ’942 patent is attached as Exhibit E.
`
`46.
`
`The ’942 Patent is assigned to Genentech, Inc., Hoffmann-La Roche Inc.,
`
`and AbbVie Inc.
`
`47.
`
`The ’087 Patent, titled “Combination Therapy of a Type II Anti-CD-20
`
`Antibody with a Selective BCL-2 Inhibitor,” was duly and legally issued by the USPTO on
`
`September 7, 2021. A true and correct copy of the ’087 patent is attached as Exhibit F.
`
`48.
`
`The ’087 Patent is assigned to Genentech, Inc., Hoffmann-La Roche Inc.,
`
`and AbbVie Inc.
`
`DRL’S ANDA
`
`49.
`
`On information and belief, DRL’s Notice Letters represent that DRL
`
`submitted and continues to maintain DRL’s ANDA to the FDA under 21 U.S.C. § 355(j).
`
`50.
`
`On information and belief, and based on DRL’s Notice Letters, DRL has
`
`submitted DRL’s ANDA to the FDA in order to obtain approval to engage in the commercial
`
`manufacture, use, or sale of venetoclax tablets as a purported generic version of VENCLEXTA®
`
`prior to the expiration of the Patents-in-suit.
`
`51.
`
`52.
`
`On information and belief, the FDA has not approved DRL’s ANDA.
`
`DRL’s June Notice Letter states that “DRL seeks to obtain approval to
`
`engage in the commercial manufacture, use, or sale of” “venetoclax tablets, 10 mg, 50 mg, 100
`
`mg.” DRL’s June Notice Letter also states that “[t]he active ingredient present in [DRL’s Generic
`
`Version] is 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-
`
`N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-
`
`b]pyridin-5-yloxy)benzamide), commonly known as venetoclax.”
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`
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`-10-
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`DRL EXHIBIT 1005 PAGE 10
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 11 of 22 PageID #: 3308
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`53.
`
`DRL’s September Notice Letter states that “DRL seeks to obtain approval
`
`to engage in the commercial manufacture, use, or sale of” “venetoclax tablets, 10 mg, 50 mg, 100
`
`mg.” DRL’s September Notice Letter also states that “[t]he active ingredient present in [DRL's
`
`Generic Version] is 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-l-yl]methyl}piperazin-
`
`1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl}sulfonyl)-2-(1H-
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`pyrrolo[2,3-b]pyridin-5-yloxy)benzamide), commonly known as venetoclax.”
`
`54.
`
`VENCLEXTA®’s Prescribing Information (“VENCLEXTA® PI”) states
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`that “VENCLEXTA® tablets for oral administration . . . contain 10, 50, or 100 mg venetoclax as
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`the active ingredient” and “[v]enetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-
`
`dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-
`
`ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide).”
`
`55.
`
`On information and belief, and as supported by DRL’s Notice Letters, by
`
`filing DRL’s ANDA, DRL has certified to the FDA that DRL’s Generic Version has the same
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`active pharmaceutical ingredient as VENCLEXTA® and either the same or similar proposed
`
`labeling as VENCLEXTA®.
`
`56.
`
`DRL’s Notice Letters represent that DRL certified in DRL’s ANDA that the
`
`claims of the ’399, ’982, ’657, and ’873 Patents are invalid or would not be infringed by the
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`commercial manufacture, use, sale, or offer for sale of DRL’s Generic Version.
`
`57.
`
`According to applicable regulations, Notice Letters such as DRL’s Notice
`
`Letters must contain a detailed statement of the factual and legal bases for the applicant’s opinion
`
`that the patent is invalid, unenforceable, or not infringed, which includes a claim-by-claim
`
`analysis, describing “[f]or each claim of a patent alleged not to be infringed, a full and detailed
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`explanation of why the claim is not infringed” and “[f]or each claim of a patent alleged to be
`
`
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`-11-
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`DRL EXHIBIT 1005 PAGE 11
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`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 12 of 22 PageID #: 3309
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`invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation.”
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`See 21 C.F.R. § 314.95(c)(7); see also 21 C.F.R. § 314.52.
`
`58.
`
`For at least one claim of each of the ’399 and ’982 Patents, DRL’s June
`
`Notice Letter failed to allege that DRL’s Generic Version or the proposed administration of DRL’s
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`Generic Version would not meet the limitations of that claim. For at least one claim of the ’657
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`Patent, DRL’s June Notice Letter failed to allege any invalidity argument.
`
`59.
`
`For at least one claim of the ’873 Patent, DRL’s September Notice Letter
`
`failed to allege any invalidity argument.
`
`60.
`
`DRL’s June Notice Letter contained an Offer of Confidential Access
`
`(“OCA”) to certain confidential information regarding DRL’s Generic Version. Plaintiffs and
`
`DRL subsequently exchanged proposed revisions to the draft OCA in an attempt to reach
`
`agreement on the terms for confidential access, but DRL refused Plaintiffs’ reasonable requests,
`
`including requests for samples of DRL’s Generic Version and active pharmaceutical ingredient.
`
`Thus, as of the filing of the original Complaint in this action, the parties had not been able to reach
`
`an agreement, and they still had not as of the filing of the First Amended Complaint.
`
`61.
`
`The limited information relating to DRL’s Generic Version that was
`
`provided in DRL’s Notice Letters does not demonstrate that DRL’s Generic Version, which DRL
`
`has asked the FDA to approve for sale in the U.S., will not fall within the scope of claims of the
`
`’399, ’982, ’657, or ’873 Patents.
`
`62.
`
`Since the filing of the original Complaint and First Amended Complaint,
`
`DRL has produced its ANDA to Plaintiffs.
`
`
`
`-12-
`
`DRL EXHIBIT 1005 PAGE 12
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`

`

`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 13 of 22 PageID #: 3310
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`63.
`
`The information relating to DRL’s Generic Version that was provided in
`
`DRL’s ANDA does not demonstrate that DRL’s Generic Version, which DRL has asked the FDA
`
`to approve for sale in the United States, will not fall within the scope of the Patents-in-Suit.
`
`64.
`
`The original Complaint in this action claimed infringement of the ’399
`
`Patent, the ’982 Patent, and the ’657 Patent and was filed within 45 days of Plaintiffs’ receipt on
`
`June 8, 2020 of DRL’s June Notice Letter, pursuant to 21 U.S.C. § 355(c)(3)(C). The First
`
`Amended Complaint included the same claim of infringement concerning the ’399 Patent, the ’982
`
`Patent, and the ’657 Patent and thus related back to the original Complaint. This Second Amended
`
`Complaint includes the same claim of infringement concerning the ’399 Patent, the ’982 Patent,
`
`and the ’657 Patent and thus relates back to the original Complaint. Accordingly, Plaintiffs remain
`
`entitled to a stay of FDA approval pursuant to 21 U.S.C. § 355(j)(5)(B)(iii) and U.S.C. §
`
`355(j)(5)(F)(ii).
`
`CLAIM FOR RELIEF
`COUNT 1: INFRINGEMENT OF THE ’399 PATENT BY DRL
`
`65.
`
`Plaintiffs restate, re-allege, and incorporate by reference paragraphs 1-64 as
`
`if fully set forth herein.
`
`66.
`
`On information and belief, DRL submitted or caused the submission of
`
`DRL’s ANDA to the FDA, and thereby seeks FDA approval of DRL’s Generic Version.
`
`67.
`
`68.
`
`DRL’s Generic Version infringes one or more claims of the ’399 Patent.
`
`DRL did not contest infringement of any claim of the ’399 Patent in DRL’s
`
`Notice Letter. If DRL had a factual or legal basis to contest infringement of the ’399 Patent, it
`
`was required by applicable regulations to state such a basis in its Notice Letter. See 21 C.F.R. §
`
`314.95(c)(7); see also 21 C.F.R. § 314.52.
`
`
`
`-13-
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`DRL EXHIBIT 1005 PAGE 13
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`

`

`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 14 of 22 PageID #: 3311
`
`69.
`
`DRL has infringed one or more claims of the ’399 Patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by submitting DRL’s ANDA with Paragraph IV certification and thereby seeking
`
`FDA approval of a generic version of VENCLEXTA®, prior to the expiration of the ’399 Patent.
`
`70.
`
`On information and belief, the importation, manufacture, sale, offer for sale,
`
`or use of DRL’s Generic Version prior to the expiration of the ’399 Patent would infringe one or
`
`more claims of the ’399 Patent under 35 U.S.C. § 271(a), and/or DRL would induce or contribute
`
`to the inducement of the infringement of one or more claims of the ’399 Patent under 35 USC §
`
`271(b) and/or (c).
`
`71.
`
`DRL had actual and constructive notice of the ’399 Patent prior to filing
`
`DRL’s ANDA, and was aware that the filing of DRL’s ANDA with the request for FDA approval
`
`prior to the expiration of the ’399 Patent would constitute an act of infringement of the ’399 Patent.
`
`72.
`
`DRL filed its ANDA without adequate justification for asserting that the
`
`’399 Patent is invalid, unenforceable, and/or not infringed by the commercial manufacture, use,
`
`offer for sale, or sale of DRL’s Generic Version.
`
`73.
`
`Plaintiffs will be irreparably harmed if DRL is not enjoined from infringing,
`
`and from actively inducing or contributing to the infringement of, the ’399 Patent. Plaintiffs do
`
`not have an adequate remedy at law and, considering the balance of hardships between Plaintiffs
`
`and DRL, a remedy in equity is warranted. Further, the public interest would not be disserved by
`
`the entry of a permanent injunction.
`
`CLAIM FOR RELIEF
`COUNT 2: INFRINGEMENT OF THE ’982 PATENT BY DRL
`
`74.
`
`Plaintiffs restate, re-allege, and incorporate by reference paragraphs 1-73 as
`
`if fully set forth herein.
`
`
`
`-14-
`
`DRL EXHIBIT 1005 PAGE 14
`
`

`

`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 15 of 22 PageID #: 3312
`
`75.
`
`On information and belief, DRL submitted or caused the submission of
`
`DRL’s ANDA to the FDA, and thereby seeks FDA approval of DRL’s Generic Version.
`
`76.
`
`77.
`
`DRL’s Generic Version infringes one or more claims of the ’982 Patent.
`
`DRL did not contest infringement of any claim of the ’982 Patent in DRL’s
`
`Notice Letter. If DRL had a factual or legal basis to contest infringement of the ’982 Patent, it
`
`was required by applicable regulations to state such a basis in its Notice Letter. See 21 C.F.R. §
`
`314.95(c)(7); see also 21 C.F.R. § 314.52.
`
`78.
`
`DRL has infringed one or more claims of the ’982 Patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by submitting DRL’s ANDA with Paragraph IV certification and thereby seeking
`
`FDA approval of a generic version of VENCLEXTA®, prior to the expiration of the ’982 Patent.
`
`79.
`
`On information and belief, the importation, manufacture, sale, offer for sale,
`
`or use of DRL’s Generic Version prior to the expiration of the ’982 Patent would infringe one or
`
`more claims of the ’982 Patent under 35 U.S.C. § 271(a), and/or DRL would induce or contribute
`
`to the inducement of the infringement of one or more claims of the ’982 Patent under 35 USC §
`
`271(b) and/or (c).
`
`80.
`
`DRL had actual and constructive notice of the ’982 Patent prior to filing
`
`DRL’s ANDA, and was aware that the filing of DRL’s ANDA with the request for FDA approval
`
`prior to the expiration of the ’982 Patent would constitute an act of infringement of the ’982 Patent.
`
`81.
`
`DRL filed its ANDA without adequate justification for asserting that the
`
`’982 Patent is invalid, unenforceable, and/or not infringed by the commercial manufacture, use,
`
`offer for sale, or sale of DRL’s Generic Version.
`
`82.
`
`Plaintiffs will be irreparably harmed if DRL is not enjoined from infringing,
`
`and from actively inducing or contributing to the infringement of, the ’982 Patent. Plaintiffs do
`
`
`
`-15-
`
`DRL EXHIBIT 1005 PAGE 15
`
`

`

`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 16 of 22 PageID #: 3313
`
`not have an adequate remedy at law and, considering the balance of hardships between Plaintiffs
`
`and DRL, a remedy in equity is warranted. Further, the public interest would not be disserved by
`
`the entry of a permanent injunction.
`
`CLAIM FOR RELIEF
`COUNT 3: INFRINGEMENT OF THE ’657 PATENT BY DRL
`
`83.
`
`Plaintiffs restate, re-allege, and incorporate by reference paragraphs 1-82 as
`
`if fully set forth herein.
`
`84.
`
`On information and belief, DRL submitted or caused the submission of
`
`DRL’s ANDA to the FDA, and thereby seeks FDA approval of DRL’s Generic Version.
`
`85.
`
`On information and belief, DRL’s Generic Version infringes one or more
`
`claims of the ’657 Patent.
`
`86.
`
`DRL has infringed one or more claims of the ’657 Patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by submitting DRL’s ANDA with Paragraph IV certification and thereby seeking
`
`FDA approval of a generic version of VENCLEXTA®, prior to the expiration of the ’657 Patent.
`
`87.
`
`On information and belief, the importation, manufacture, sale, offer for sale,
`
`or use of DRL’s Generic Version prior to the expiration of the ’657 Patent would infringe one or
`
`more claims of the ’657 Patent under 35 U.S.C. § 271(a), and/or DRL would induce or contribute
`
`to the inducement of the infringement of one or more claims of the ’657 Patent under 35 USC §
`
`271(b) and/or (c).
`
`88.
`
`DRL had actual and constructive notice of the ’657 Patent prior to filing
`
`DRL’s ANDA, and was aware that the filing of DRL’s ANDA with the request for FDA approval
`
`prior to the expiration of the ’657 Patent would constitute an act of infringement of the ’657 Patent.
`
`
`
`-16-
`
`DRL EXHIBIT 1005 PAGE 16
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`

`

`Case 1:20-cv-00968-MSG Document 77 Filed 10/19/21 Page 17 of 22 PageID #: 3314
`
`89.
`
`DRL filed its ANDA without adequate justification for asserting that the
`
`’657 Patent is invalid, unenforceable, and/or not infringed by the commercial manufacture, use,
`
`offer for sale, or sale of DRL’s Generic Version.
`
`90.
`
`Plaintiffs will be irreparably harmed if DRL is not enjoined from infringing,
`
`and from actively inducing or contributing to the infringement of, the ’657 Patent. Plaintiffs do
`
`not have an adequate remedy at law and, considering the balance of hardships between Plaintiffs
`
`and DRL, a remedy in equity is warranted. Further, the public interest would not be disserved by
`
`the entry of a permanent injunction.
`
`CLAIM FOR RELIEF
`COUNT 4: INFRINGEMENT OF THE ’873 PATENT BY DRL
`
`91.
`
`Plaintiffs restate, re-allege, and incorporate by reference paragraphs 1-90
`
`as if fully set forth herein.
`
`92.
`
`On information and belief, DRL submitted or caused the submission of
`
`DRL’s ANDA to the FDA, and thereby seeks FDA approval of DRL’s Generic Version.
`
`93.
`
`On information and belief, DRL’s Generic Version infringes one or more
`
`claims of the ’873 Patent.
`
`94.
`
`DRL has infringed one or more claims of the ’873 Patent under 35 U.S.C.
`
`§ 271(e)(2)(A) by submitting DRL’s ANDA with Paragraph IV certification and thereby seeking
`
`FDA approval of a generic version of VENCLEXTA®, prior to the expiration of the ’873 Patent.
`
`95.
`
`On information and belief, the importation, manufacture, sale, offer for sale,
`
`or use of DRL’s Generic Version prior to the expiration of the ’873 Patent would infringe one or
`
`more claims of the ’873 Patent under 35 U.S.C. § 271(a), and/or DRL would induce or contribute
`
`to the inducement of the infringement of one or more claims of the ’873 Patent under 35 USC §
`
`271(b) and/or (c).
`
`
`
`-17-
`
`DRL EXHIBIT 10